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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for Tackling Tuberculosis in the Time of COVID-19: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26530.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Claire Biffl, Julie Liao, Anna Nicholson, Rapporteurs Forum on Microbial Threats Board on Global Health Health and Medicine Division PREPUBLICATION COPY—Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS   500 Fifth Street, NW   Washington, DC 20001 This activity was supported by a contract between the National Academy of Sci- ences and the U.S. Agency for International Development (10004113). Any opin- ions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/26530 This publication is available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http:// www.nap.edu. Copyright 2022 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Innovations for tackling Tuberculosis in the time of COVID-19: Proceed- ings of a workshop. Washington, DC: The National Academies Press. https://doi. org/10.17226/26530. PREPUBLICATION COPY—Uncorrected Proofs

The National Academy of Sciences was established in 1863 by an Act of Con- gress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the char- ter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. PREPUBLICATION COPY—Uncorrected Proofs

Consensus Study Reports published  by the National Academies of Sciences, Engineering, and Medicine  document the evidence-based consensus  on the study’s statement of task by an authoring committee of experts. Reports typi- cally include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opin- ions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. Rapid Expert Consultations published by the National Academies of Sciences, Engineering, and Medicine are authored by subject-matter experts on narrowly focused topics that can be supported by a body of evidence. The discussions con- tained in rapid expert consultations are considered those of the authors and do not contain policy recommendations. Rapid expert consultations are reviewed by the institution before release. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. PREPUBLICATION COPY—Uncorrected Proofs

COMMITTEE ON INNOVATIONS FOR TACKLING TUBERCULOSIS IN THE TIME OF COVID-19: A TWO-PART WORKSHOP1 GAIL H. CASSELL (Co-Chair), Senior Lecturer on Global Health and Social Medicine, Harvard Medical School KENNETH G. CASTRO (Co-Chair), Professor of Global Health, Epidemiology, and Infectious Diseases, Rollins School of Public Health and School of Medicine, Emory University EMILY ABRAHAM, Director, External Affairs and Policy, Global Public Health at Johnson & Johnson ANDREW CLEMENTS, Senior Technical Advisor, Emerging Threats Division, U.S. Agency for International Development LUCICA DITIU, Executive Director, Stop TB Partnership, United Nations Office for Project Services MARCOS A. ESPINAL, Director, Communicable Diseases and Environmental Determinants of Health, Pan American Health Organization HAMIDAH HUSSAIN, Global Technical Lead, IRD TEREZA KASAEVA, Director, Global Tuberculosis Programme, World Health Organization KENT E. KESTER, Vice President and Head, Translational Science and Biomarkers, Sanofi Pasteur MONIQUE K. MANSOURA, Executive Director, Global Health Security and Biotechnology, MITRE PETER SANDS, Executive Director, The Global Fund to Fight AIDS, Tuberculosis and Malaria CHARLES WELLS, Head of Therapeutics Development, Bill & Melinda Gates Medical Research Institute National Academies Staff JULIE LIAO, Director, Forum on Microbial Threats ELIZABETH ASHBY, Associate Program Officer CHARLES MINICUCCI, Research Assistant CLAIRE BIFFL, Research Assistant JULIE PAVLIN, Senior Board Director 1  The planning committee’s role was limited to planning the workshop, and the Proceed- ings of a Workshop was prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus. v PREPUBLICATION COPY—Uncorrected Proofs

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FORUM ON MICROBIAL THREATS1 PETER DASZAK (Chair), President, EcoHealth Alliance KENT E. KESTER (Vice Chair), Vice President and Head, Translational Science and Biomarkers, Sanofi Pasteur RIMA F. KHABBAZ (Vice Chair), Director, National Center for Emerging Zoonotic Infectious Diseases, U.S. Centers for Disease Control and Prevention EMILY ABRAHAM, Director, External Affairs and Policy, Global Public Health at Johnson & Johnson KEVIN ANDERSON, Senior Program Manager, Science and Technology Directorate, U.S. Department of Homeland Security CRISTINA CASSETTI, Deputy Division Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases ANDREW CLEMENTS, Senior Technical Advisor, Emerging Threats Division, U.S. Agency for International Development SCOTT F. DOWELL, Deputy Director for Surveillance and Epidemiology, Bill & Melinda Gates Foundation MARCOS A. ESPINAL, Director, Communicable Diseases and Environ- mental Determinants of Health, Pan American Health Organization EVA HARRIS, Professor, Division of Infectious Diseases and Vaccinology; Director, Center for Global Public Health, University of California, Berkeley School of Public Health ELIZABETH D. HERMSEN, Head, Global Antimicrobial Stewardship and Health Equity in Infectious Diseases, Merck & Co., Inc. CHRISTOPHER R. HOUCHENS, Director, Division of Chemical, Biological, Radiological and Nuclear Countermeasures, Biomedical Advanced Research and Development Authority CHANDY C. JOHN, Director, Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine and Riley Hospital for Children at IU Health MARK G. KORTEPETER, Vice President for Research, Professor of Preventive Medicine and Medicine, Uniformed Services University of the Health Sciences 1  The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution. vii PREPUBLICATION COPY—Uncorrected Proofs

MICHAEL MAIR, Acting Assistant Commissioner for Counterterrorism Policy; Acting Director, Office of the Chief Scientist, U.S. Food and Drug Administration JONNA A. K. MAZET, Vice Provost – Grand Challenges; Chancellor’s Leadership Professor of Epidemiology & Disease Ecology, University of California, Davis VICTORIA MCGOVERN, Senior Program Officer, Burroughs Wellcome Fund SALLY A. MILLER, Distinguished Professor of Food, Agricultural and Environmental Sciences in Plant Pathology, The Ohio State University, College of Food, Agriculture, and Environmental Sciences SUERIE MOON, Director of Research, Global Health Centre; Visiting Lecturer, graduate Institute of International and Development Studies; Adjunct Lecturer, Harvard T.H. Chan School of Public Health RAFAEL OBREGON, Country Representative, UNICEF Paraguay KUMANAN RASANATHAN, Unit Head for Equity and Health, Department of Social Determinants of Health, World Health Organization GARY A. ROSELLE, Executive Director, National Infectious Disease Services Program, Veterans Health Administration, U.S. Department of Veterans Affairs PETER A. SANDS, Executive Director, The Global Fund to Fight AIDS, Tuberculosis & Malaria THOMAS W. SCOTT, Distinguished Professor, Department of Entomology and Nematology, University of California, Davis MATTHEW ZAHN, Deputy Health Officer, Orange County Health Care Agency National Academies of Sciences, Engineering, and Medicine Staff JULIE LIAO, Director, Forum on Microbial Threats ELIZABETH ASHBY, Associate Program Officer CHARLES MINICUCCI, Research Assistant (until September 2021) CLAIRE BIFFL, Research Assistant JUSTIN HAMMERBERG, Senior Program Assistant (from January 2022) JULIE PAVLIN, Senior Board Director viii PREPUBLICATION COPY—Uncorrected Proofs

Reviewers T his Proceedings of a Workshop was reviewed in draft form by indi- viduals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engi- neering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review com- ments and draft manuscript remain confidential to protect the integrity of the process. We thank the following individuals for their review of this proceedings: KUNCHOK DORJEE, Johns Hopkins University ANNA MARIA MANDALAKAS, Baylor College of Medicine ELTONY MUGOMERI, Africa University Although the reviewers listed above provided many constructive com- ments and suggestions, they were not asked to endorse the content of this proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by ANN M. ARVIN, Stanford University. She was responsible for making certain that an independent examination of this proceedings was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies. ix PREPUBLICATION COPY—Uncorrected Proofs

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Acknowledgments T he workshop summarized in this proceedings is the product of many valuable contributions. Special thanks go to the presenters and dis- cussants who gave generously of their time and expertise to make the event possible. xi PREPUBLICATION COPY—Uncorrected Proofs

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Contents ACRONYMS AND ABBREVIATIONS XIX 1 INTRODUCTION 1 Workshop Objectives, 2 Organization of the Proceedings of the Workshop, 3 2 CURRENT TOOLS AND CHALLENGES 5 Leadership FROM Public Health Workers In Ending Tuberculosis—Past And Present, 6 Progress Toward Global Tuberculosis Elimination Goals and Opportunities for Moving Forward, 8 Challenges and Innovations, 12 New Technologies and Remaining Gaps in TB Diagnostics, 14 Improving Treatment Regimens and Vaccine Development, 17 Collective Social Value of Infectious Disease Interventions, 20 Discussion, 23 3 DETECTION 29 USAID’s Commitment to Addressing Tuberculosis Worldwide, 30 Building a Tuberculosis-Free World: Progress Update, 32 Realities of MultiDrug-Resistant Tuberculosis, 37 Rapid Acceleration of Diagnostics Technology: COVID-19 Pandemic Experience, 41 Advances in Tuberculosis Diagnostics, 47 xiii PREPUBLICATION COPY—Uncorrected Proofs

xiv CONTENTS Innovations for Tackling Tuberculosis in the Time of COVID-19, 48 Improving X-ray Accessibility, 49 Implementation Challenges with New Tuberculosis Diagnostics, 50 Improving Adherence, Infection Control Capacities, and Cost-Effectiveness, 51 Telehealth and Digital Adherence Technologies, 54 Innovative Strategies to Synergize Investments in Health Care Systems, 58 Environmental Transmission Control Lessons from COVID-19 and Tuberculosis, 63 Gaps and Opportunities in Management of Latent Tuberculosis Infection, 67 4 VACCINES AND THERAPEUTICS 73 Existing Tools and New Technologies, 74 Pathway to Effective Tuberculosis Vaccines: Promising New Adjuvants and Late-Stage Clinical Development Vaccine Candidates, 78 Advances in Host-Directed Therapeutics for Antibiotic- Resistant Tuberculosis, 82 Immune Mechanisms of Protection Against Tuberculosis, 85 Transforming Treatment Options, 88 Rolling Out a New Treatment Regimen for Drug-Resistant Tuberculosis: Industry Perspective, 94 Implementing a New Treatment Regimen for Drug-Resistant Tuberculosis: Lessons Learned, 98 Bringing Innovation to the Development of New Transformative TB Regimens, 102 Economic Analysis of Novel Tuberculosis Treatment Regimens, 106 Reflections and Discussion on Critical Elements for Implementation, 111 Framing Tuberculosis as a Global Health Emergency, 115 Discussion, 117 5 FINANCING, AMBITION, AND PREPAREDNESS 123 A Place for Tuberculosis in the Pandemic Preparedness Agenda, 125 Achieving Synergy in Global Health Security Preparedness Against Respiratory Pathogens, 132 Making the Case for Financing Tuberculosis Elimination, 142 Final Comments, 153 PREPUBLICATION COPY—Uncorrected Proofs

CONTENTS xv APPENDIXES A REFERENCES 155 B WORKSHOP STATEMENT OF TASK 163 C WORKSHOP AGENDA 165 PREPUBLICATION COPY—Uncorrected Proofs

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Boxes, Figures, and Table BOXES 2-1 Progress in Reducing the Global Tuberculosis Burden, 9 2-2 Challenges and Opportunities in Advancing Tuberculosis Diagnostics, 17 3-1 Investment Priorities for Ending Tuberculosis, 34 3-2 Point-of-Care Technologies Research Network, 42 3-3 Research Priorities in the Cascade of Tuberculosis Prevention, 68 4-1 Overview of Lessons Learned from TBTC Study 31/A5349, 94 4-2 Lessons Learned from the Rollout of Bedaquiline in South Africa, 101 4-3 Performance-Based Monitoring and Evaluation Framework: Core Indicators, 114 FIGURES 2-1 Relative differences in diphtheria, tetanus, and pertussis vaccine dose 3 (2019 versus 2020), 11 3-1 Progress toward 2018–2022 global targets for the number of people treated for tuberculosis, 40 3-2 Preparedness framework, 59 xvii PREPUBLICATION COPY—Uncorrected Proofs

xviii BOXES, FIGURES, AND TABLE 4-1 Bacillus Calmette–Guérin vaccination policies worldwide, 75 4-2 Potential uses of a tuberculosis vaccine, 79 4-3 Primary efficacy results for Tuberculosis Trials Consortium Study 31/AIDS Clinical Trials Group A5349, 90 4-4 USAID’s Performance-Based Monitoring and Evaluation Framework (PBMEF), 113 TABLE 4-1 Optimal Pan-Tuberculosis Target Regimen Profile, 104 PREPUBLICATION COPY—Uncorrected Proofs

Acronyms and Abbreviations AMR antimicrobial resistance AU Africa University BARDA Biomedical Advanced Research and Development Authority BCG Bacillus Calmette-Guérin BMGF Bill and Melinda Gates Foundation CEPI Coalition for Epidemic Preparedness Innovations CHW community health worker DALY disability-adjusted life year DARPA Defense Advanced Research Projects Agency DAT digital adherence technologies DOTS directly observed treatment, short-course DR TB drug-resistant tuberculosis DS TB drug-susceptible tuberculosis DST drug-susceptibility testing ECG electrocardiogram FDA U.S. Food and Drug Administration GDF Global Drug Facility GDP gross domestic product xix PREPUBLICATION COPY—Uncorrected Proofs

xx ACRONYMS AND ABBREVIATIONS GHSA global health security agenda GPH global public health HIV human immunodeficiency virus HLIP High Level Independent Panel HR human resources HTA health technology assessment ICEC International Cancer Expert Corps IDA International Development Association IFI international financial institutions IGRA interferon gamma release assay IHR International Health Regulations IMF International Monetary Fund IMI Innovative Medicines Initiative IRB institutional review board IRD Interactive Research and Development J&J Johnson and Johnson LMIC low- and middle-income country MCM medical countermeasures MDG Millennium Development Goal MDR TB multi-drug resistant tuberculosis mRNA messenger RNA NGO non-governmental organization NHP non-human primate NIH National Institutes of Health PAN-TB Project to Accelerate New Treatments for Tuberculosis PCR polymerase chain reaction PEPFAR President’s Emergency Plan for AIDS Relief POC point-of-care POCTRN Point-of-Care Technologies Research Network PPR pandemic preparedness and response R&D research and development ROI return on investment RR TB rifampicin-resistant tuberculosis SDG Sustainable Development Goal PREPUBLICATION COPY—Uncorrected Proofs

ACRONYMS AND ABBREVATIONS xxi TB                tuberculosis  TBDA TB Drug Accelerator TPT tuberculosis preventive therapy TRF The Rockefeller Foundation TRP target regimen profile TPP target product profile TST tuberculin or tuberculosis skin test UDR universal drug regimen UHC universal health care UN United Nations UNHLM United Nations High-Level Meeting USAID United States Agency for International Development WHO            World Health Organization  XDR TB extensively drug-resistant tuberculosis PREPUBLICATION COPY—Uncorrected Proofs

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Despite being preventable and curable since the middle of the twentieth century, tuberculosis (TB) has long persisted as the world's deadliest infectious disease, with the communities most devastated by TB among the poorest and most vulnerable in the world. Only about half of people with TB receive successful treatment each year. As the global threat of antimicrobial resistance continues to escalate, so do cases of drug-resistant TB, or TB that is resistant to various antibiotics that constitute standard treatment regimens.

In response, the National Academies of Sciences, Engineering, and Medicine's Forum on Microbial Threats held a two-part virtual workshop on July 22 and September 14-16, 2021 titled Innovations for Tackling Tuberculosis in the Time of COVID-19. The aims of the workshop were to evaluate the current status of TB elimination, assess the effects of the COVID-19 pandemic on the global fight against TB, and examine technical and strategic innovations that could be leveraged to meet the United Nations High-Level Meeting on Tuberculosis targets in 2022 and The World Health Organization's END TB Strategy targets by 2030. This publication summarizes the presentations and discussions of the workshop.

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